Head modeling for a therapeutic or diagnostic procedure

ABSTRACT

A model of a human subject&#39;s head may be generated to assist in a therapeutic and/or diagnostic procedure. A treatment and/or diagnostic system may generate a fitted head model using a predetermined head model and a plurality of points. The plurality of points may include facial feature information and may be determined using a sensor, for example, an IR or optical sensor. One or more anatomical landmarks may be determined and registered in association with the fitted head model using the facial feature information, for example, without the use of additional image information, such as an MRI image. The fitted head model may include visual aids, for example, anatomical landmarks, reference points, marking of the human subject&#39;s MT location, and/or marking of the human subject&#39;s treatment location. The visual aids may assist a technician to perform the therapeutic and/or diagnostic procedure of the human subject.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.14/618,407, filed Feb. 10, 2015, which claims the benefit of U.S.Provisional Application No. 61/937,951, filed Feb. 10, 2014, thedisclosure of which is incorporated herein by reference in its entirety.

BACKGROUND

A number of medical ailments are treated or treatable through theapplication of electrical stimulation to an afflicted portion of a humansubject's body. Examples of electrical stimulation may include magneticor inductive stimulation, which may make use of a changing magneticfield, and electric or capacitive stimulation in which an electric fieldmay be applied to the tissue. Neurons, muscle, and tissue cells areforms of biological circuitry capable of carrying electrical signals andresponding to electrical stimuli. For example, when an electricalconductor is passed through a magnetic field, an electric field isinduced causing current to flow in the conductor. Because various partsof the body may act as a conductor, when a changing magnetic field isapplied to the portion of the body, an electric field is created causingcurrent to flow. In the context of biological tissue, for example, theresultant flow of electric current stimulates the tissue by causingneurons in the tissue to depolarize. Also, in the context of muscles,for example, muscles associated with the stimulated neurons contract. Inessence, the flow of electrical current allows the body to stimulatetypical and often desired chemical reactions.

Electrical stimulation has many beneficial and therapeutic biologicaleffects. For example, the use of magnetic stimulation is effective inrehabilitating injured or paralyzed muscle groups. Another area in whichmagnetic stimulation is proving effective is treatment of the spine. Thespinal cord is difficult to access directly because vertebrae surroundit. Magnetic stimulation may be used to block the transmission of painvia nerves in the back (e.g., those responsible for lower back pain).Further, unlike the other medical procedures that stimulate the body,electrical stimulation may be non-invasive. For example, using magneticfields to generate current in the body produces stimulation by passingthe magnetic field through the skin of a human subject.

Magnetic stimulation also has proven effective in stimulating regions ofthe brain, which is composed predominantly of neurological tissue. Onearea of particular therapeutic interest is the treatment ofneuropsychiatric disorders. It is believed that more than 28 millionpeople in the United States alone suffer from some type ofneuropsychiatric disorder. These include specific conditions such asdepression, schizophrenia, mania, obsessive-compulsive disorder, panicdisorders, just to name a few. One particular condition, depression, isthe often referred to as the “common cold” of psychiatric disorders,believed to affect 19 million people in the United States alone, andpossibly 340 million people worldwide. Modern medicine offers depressionhuman subjects a number of treatment options, including several classesof anti-depressant medications like selective serotonin reuptakeinhibitors (SSRI), MAIs, tricyclics, lithium, and electroconvulsivetherapy (ECT). Yet many human subjects remain without satisfactoryrelief from the symptoms of depression.

Repetitive transcranial magnetic stimulation (rTMS) has been shown tohave anti-depressant effects for human subjects, even those that do notrespond to the traditional methods and medications. For example, asubconvulsive stimulation may be applied to the prefrontal cortex in arepetitive manner, causing a depolarization of cortical neuronmembranes. The membranes are depolarized by the induction of smallelectric fields, usually in excess of 1 volt per centimeter (V/cm).These small electric fields result from a rapidly changing magneticfield applied non-invasively.

Therapeutic and diagnostic procedures, such as TMS for example, mayrequire a technician to locate a treatment location (e.g., or targetlocation that is used to determine the treatment location) beforeperforming the therapeutic and/or diagnostic procedure. This process canbe time consuming and burdensome. For example, the technician may berequired to manually collect multiple points on a patient one-by-one togenerate a model of the patient, and after the model is generated,locate the treatment location on the model.

SUMMARY

A system for creating a model, such as a fitted head model, may beprovided. The system may comprise a sensor, a processor, a memory, atransceiver, a power supply, a treatment coil, and/or a display device.The processor may be configured to determine a plurality of pointsassociated with the human subject's head using the sensor. For example,the processor may be configured to determine a plurality of points usingthe sensor and without the use of an indicator tool. The sensor maycomprise an infrared (IR) sensor. One or more (e.g., each) of theplurality of points that are associated with the human subject's headmay comprises an x coordinate, a y coordinate, and a z coordinate in acoordinate system (e.g., Cartesian coordinate system, a cylindricalcoordinate system, and/or the like). A subset of the plurality of pointsmay comprise facial feature information relating to the human subject.The facial feature information may include information relating to alocation of one or more facial features of the human subject, such as,but not limited to a nose, an eye, an ear, chin, hairline, and/or mouthof the human subject.

The processor may be configured to generate a fitted head model using apredetermined head model and the plurality of points. For example, theprocessor may be configured to generate the fitted head model using acubic spline method. The processor may be configured to, for example,morph the predetermined head model to the plurality of points togenerate the fitted head model. The predetermined head model may be ageneric head model that does not include any characteristics that arespecific to one individual. The predetermined head model may includelocation information relating to the one or more anatomical landmarks.An anatomical landmark may comprise a nasion, an inion, a lateralcanthus, an external auditory meatus (e.g., ear attachment point),and/or one or more preauricular points of the human subject. Ananatomical landmark may be associated with an x coordinate, a ycoordinate, and a z coordinate of the predetermined head model. Thepredetermined head model may comprise predefined coordinates, forexample, such as an Electroencephalography (EEG) 10-20 coordinate grid,one or more treatment locations, and/or the like.

The fitted head model may have a smooth surface. For example, theprocessor may be configured to determine that one or more points of theplurality of points are associated with rippling of the human subject'sskin, loss of a facial feature, and/or an asymmetric lump, and generatethe fitted head model without the use of the points associated with therippling of the human subject's skin, loss of a facial feature, orasymmetric lump. The fitted head model may not include the humansubject's hair. For example, the plurality of points that are used tocreate the fitted head model may be devoid of information relating tothe human subject's hair such that the fitted head model is devoid ofinformation relating to the human subject's hair. The processor may beconfigured to determine that one or more points of the plurality ofpoints that are used to create the fitted head model are associated withthe human subject's hair, and the processor may be configured togenerate the fitted head model without the use of the points associatedwith the human subject's hair. The fitted head model may comprise an EEG10-20 coordinate grid.

The processor may be configured to determine a location of one or moreanatomical landmarks on the fitted head model using the facial featureinformation. For example, the processor may be configured to performtriangulation and/or trilateration using the facial feature information(e.g., one or more points associated with the facial featureinformation) to determine the location of one or more anatomicallandmarks of the human subject on the fitted head model. An anatomicallandmark may be associated with an x coordinate, a y coordinate, and a zcoordinate of the fitted head model. The processor may be configured toregister the anatomical landmarks with the fitted head model.

The processor may be configured to determine a target location on thefitted head model based on one or more anatomical landmarks. Forexample, the processor may be configured to determine a target locationon the fitted head model based on one or more anatomical landmarkswithout the use of additional image information, for example, such as,but not limited to magnetic resonance imaging (MRI) image information,x-ray image information, and/or the like. The target location maycomprise a treatment location or a reference point that may be used todetermine the treatment location. The processor may be configured todisplay the fitted head model and the target location on the displaydevice, for example, to assist in a therapeutic or diagnostic procedure.The processor may be configured to perform transcranial magneticstimulation (TMS) using the fitted head model and/or the targetlocation. The fitted head model may be saved for the human subject, forexample, so that it can be recalled and used during a subsequenttherapeutic or diagnostic procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a diagram of an example of a treatment system.

FIG. 2 is a diagram of an example of a sensor.

FIG. 3 is a flowchart of an example procedure for creating a fitted headmodel.

FIG. 4 is a diagram of an example of a predetermined head model, a pointcloud, and a fitted head model.

FIG. 5 is a diagram of an example of a predetermined head modelsuperimposed with a plurality of points determined by a sensor.

FIG. 6 is a diagram of an example fitted head model that includes an EEG10-20 coordinate grid.

FIG. 7 is a diagram of example procedures for preparing for and/orperforming a therapeutic and/or diagnostic procedure.

DETAILED DESCRIPTION

A detailed description of illustrative embodiments will now be describedwith reference to the various Figures. Although this descriptionprovides a detailed example of possible implementations, it should benoted that the details are intended to be examples and in no way limitthe scope of the application.

In 1831, Michael Faraday discovered that the magnitude of an electricfield induced on a conductive loop is proportional to the rate of changeof magnetic flux that cuts across the area of the conductive loop.Faraday's law may be represented as E˜−(dB/dt), where E is the inducedelectric field in volts/meter, dB/dt is the time rate of change ofmagnetic flux density in Tesla/second. In other words, the amount ofelectric field induced in an object like a conductor may be determinedby two factors: the geometry and the time rate of change of the flux.The greater the derivative of the magnetic flux, the greater the inducedelectric field and resulting current density. Because the magnetic fluxdensity decreases quickly with distance from the source of the magneticfield, the flux density is greater the closer the conductor is to thesource of the magnetic field. When the conductor is a coil, the currentinduced in the coil by the electric field may be increased in proportionto the number of turns of the coil.

When the electric field is induced in a conductor, the electric fieldcreates a corresponding current flow in the conductor. The current flowis in the same direction of the electric field vector at a given point.The peak electric field occurs when dB/dt is the greatest and diminishesat other times. If the magnetic field changes, for example during amagnetic pulse, the current flows in a direction that tends to preservethe magnetic field (e.g., Lenz's Law).

In the context of electrical stimulation of the anatomy, certain partsof the anatomy (e.g., nerves, tissue, muscle, brain) act as a conductorand carry electric current when an electric field is presented. Theelectric field may be presented to these parts of the anatomytranscutaneously by applying a time varying (e.g., pulsed) magneticfield to the portion of the body. For example, in the context of TMS, atime-varying magnetic field may be applied across the skull to create anelectric field in the brain tissue, which produces a current. If theinduced current is of sufficient density, neuron membrane potential maybe reduced to the extent that the membrane sodium channels open and anaction potential response is created. An impulse of current is thenpropagated along the axon membrane which transmits information to otherneurons via modulation of neurotransmitters. Such magnetic stimulationhas been shown to acutely affect glucose metabolism and local blood flowin cortical tissue. In the case of major depressive disorder,neurotransmitter dysregulation and abnormal glucose metabolism in theprefrontal cortex and the connected limbic structures may be a likelypathophysiology. Repeated application of magnetic stimulation to theprefrontal cortex may produce chronic changes in neurotransmitterconcentrations and metabolism so that depression is alleviated.

Before beginning a therapeutic and/or diagnostic procedure on a humansubject, the size and the shape of the human subject's head may bedetermined. This determination may be made in order to properlydetermine where and how the procedure is to be performed on the specifichuman subject. Since each human subject's head size and shape may beunique and since the margin of error when determining these locationsmay be low, accurate means for determining the size and shape of thehuman subject's head may be a time consuming and delicate procedure.Further, replicating theses determinations for each human subject and/orfor each procedure for a human subject may be difficult. As such, thedetermination of the size and shape of the human subject's head may beperformed one time before the first procedure for the human subject andsaved for use during subsequent procedures.

FIG. 1 is a diagram of an example of a treatment system. The treatmentsystem 100 may comprise a processor (not shown), a power supply (notshown), memory (not shown), a transceiver, (not shown), a treatment coil102, an articulating arm 104, a display device 106, a sensor 110, and/ora human subject positioning apparatus 122. The treatment system 100 maybe stationary or movable. For example, the treatment system 100 may beintegrated into a movable cart, for example, as shown in FIG. 1. In oneor more examples, the treatment system 100 may be a TMS treatment system(e.g., NeuroStar®) and/or any other therapeutic and/or diagnosticprocedure system. The treatment coil 102 may be used to administer atherapeutic and/or diagnostic procedure to a human subject 120, forexample, TMS. Although illustrated to include a treatment coil 102, thetreatment system 100 may include any device for administration oftherapeutic and/or diagnostic procedure of the human subject. Thetreatment system 100 may be used for a diagnostic procedure (e.g.,solely for a diagnostic procedure).

The processor of the treatment system 100 may be a general purposeprocessor, a special purpose processor, a conventional processor, adigital signal processor (DSP), a plurality of microprocessors, one ormore microprocessors in association with a DSP core, a controller, amicrocontroller, Application Specific Integrated Circuits (ASICs), FieldProgrammable Gate Array (FPGAs) circuits, any other type of integratedcircuit (IC), a state machine, and the like. The processor may performsignal coding, data processing, power control, input/output processing,and/or any other functionality that enables the treatment system 100 tooperate. The processor may be integrated together with one or more othercomponents of the treatment system 100 in an electronic package or chip.

The processor of the treatment system 100 may be coupled to and mayreceive user input data from and/or output user input data to thetreatment coil 102, the articulating arm 104, the display device 106(e.g., a liquid crystal display (LCD) display unit or organiclight-emitting diode (OLED) display unit), the sensor 110, and/or thehuman subject positioning apparatus 122. The processor may accessinformation from, and store data in, any type of suitable memory, suchas non-removable memory and/or removable memory. The non-removablememory may include random-access memory (RAM), read-only memory (ROM), ahard disk, or any other type of memory storage device. The removablememory may include a subscriber identity module (SIM) card, a memorystick, a secure digital (SD) memory card, and the like. The processormay access information from, and store data in, memory that is notphysically located within the treatment system 100, such as on a server(not shown).

The processor may receive power from the power supply, and may beconfigured to distribute and/or control the power to the othercomponents in the treatment system 100. The power supply may be anysuitable device for powering the treatment system 100.

The human subject 120 may be positioned within the human subjectpositioning apparatus 122. The human subject positioning apparatus 122may be a chair, recliner, bed, stool, and/or the like. When performingtreatment, the treatment coil 102 may be situated such that the humansubject's head is positioned under the treatment coil 102. The treatmentcoil 102 may be adjusted by means of the articulating arm 104 and/or thelike.

The treatment system 100 may comprise one or more computer softwareapplications running on the processor. The computer softwareapplications may provide a system graphical user interface (GUI) (e.g.,a TMS system GUI) on the display device 106. The computer softwareapplications may incorporate work flow management to guide a technicianthrough the therapeutic and/or diagnostic procedure, and/or superviseand/or control one or more subsystems of the treatment system 100. Forexample, the computer software applications may control internal systemfunctions, monitor the system status to ensure safe operation, and/orprovide the user with a graphical means to manage the preparation forand/or the administration of the therapeutic and/or diagnosticprocedure.

Interaction with the computer software applications may be provided viaa user interface. In one or more embodiments, the user interface may bethe display device 106, which may be a touch screen display. The displaydevice 106 may include touch activated images of alphanumeric keysand/or buttons for user interaction with the treatment system 100. Thedisplay device 106 may provide graphic representations of the systemactivity, messages, and/or alarms. Interactive buttons, fields, and/orimages may be displayed via the display device 106, and may enable thetechnician to direct and/or interact with system functions, for example,such as entering data, starting and stopping the procedure, runningdiagnostics, adjusting positioning and/or configuration of the treatmentcoil 102, adjusting the position of one or more sensor(s) (e.g., sensor110), and/or the like.

The sensor 110 may comprise an infra-red (IR) sensor (e.g., IR camera),an ultrasonic transducer, an image sensor, a color sensor, a lightsensor, a radio-frequency (RF) sensor, a tilt sensor, a microphonearray, a laser scanner, and/or the like. Although illustrated as a fixeddevice, the sensor 110 may be mobile. The sensor 110 may communicatewith the processor of the treatment system 100 via a wired interface(e.g., as shown) and/or wireless interface (e.g., radio frequency (RF)communication, such as, but not limited to WiFi®, Bluetooth®, LTE®,and/or the like). Although one sensor 110 is illustrated, the treatmentsystem 100 may comprise more than one sensor 110.

The sensor 110 may be used to create a 2D and/or 3D digitalreconstruction of the human subject's head, which for example, mayinclude a fitted head model. For example, the sensor 110 may be used todetermine one or more points (e.g., the cloud of points) associated withthe human subject's head. The sensor 110 may be used to register one ormore anatomical landmarks associated with the human subject's head. Thesensor 110 may determine (e.g., capture) a cloud of points and/orperform anatomical landmark registration with or without the use of anindicator tool. The indicator tool may be a second sensor, the finger ofthe technician, an additional tool, etc. The sensor 110 may use anadditional tool to assist in one or more of the procedures describedherein. For example, the additional tool used by the treatment system100 may include active and/or passive components to aid in detection bythe sensor 110. For example, a reflector may be an example of a passivecomponent/tool, while an LED may be an example of an activecomponent/tool.

The treatment system 100 may determine the size and/or shape of a humansubject's head to generate a fitted head model, for example, a fittedhead model of the human subject 120. The fitted head model may be a twodimensional (2D) or a three dimensional (3D) model. An example of afitted head model is illustrated in FIG. 4. The fitted head model may beused to assist in a therapeutic and/or diagnostic procedure of the humansubject 120. The treatment system 100 may store the fitted head model inmemory. For example, the treatment system may use polygonal mesh (e.g.,as a mathematical structure) to store the fitted head model.

The treatment system 100 may be used for any therapeutic and/ordiagnostic procedure. For example, the treatment system may be used forTMS, tDCS, EEG, DBS, a diagnostic procedure, and/or the like. Forexample, the treatment system 100 may be used for any therapeutic and/ordiagnostic procedure that includes the placement of electrodes, sensors,probes, and/or the like on a human subject, such as on the surface of ahuman subject's head. Although described with reference to a head model,the treatment system 100 may be configured to generate a model of anypart of the human subject 120, such as, but not limited to, the arm,neck, chest, leg, and/or the like. The treatment system 100 may generatethe fitted head model using the sensor 110.

FIG. 2 is a diagram of an example of a sensor. The sensor 200 may beused with a treatment system (e.g., the treatment system 100). Thesensor 220 may be an example of the sensor 110 of the treatment system100. The sensor 200 may comprise a processor 201, memory 202, a powersupply 203, an IR emitter 204, an IR depth sensor 205, a color sensor206, a tilt monitor 207, a microphone array 208 (e.g., which maycomprises one or more microphones), and/or other peripherals 209 (e.g.,a transceiver). In an example, the sensor 200 may comprise the Kinect®system made by Microsoft® and/or an equivalent 3D IR depth sensingcamera. The sensor 200 may include software that can be used to performfacial recognition, motion capture, video recording, and/or the like.The sensor 200 may include a user interface (e.g., a touch screen)and/or the sensor 200 may use the user interface (e.g., the displaydevice 106) of the treatment system. The sensor 200 may be a fixed ormobile device. The sensor 200 may communicate with the processor of thetreatment system 100 via a wired interface and/or a wireless interface.

The processor 201 of the sensor 200 may be a general purpose processor,a special purpose processor, a conventional processor, a digital signalprocessor (DSP), a plurality of microprocessors, one or moremicroprocessors in association with a DSP core, a controller, amicrocontroller, Application Specific Integrated Circuits (ASICs), FieldProgrammable Gate Array (FPGAs) circuits, any other type of integratedcircuit (IC), a state machine, and the like. The processor 201 mayperform signal coding, data processing, power control, input/outputprocessing, and/or any other functionality that enables the sensor 200to operate. The processor 200 may be integrated together with one ormore other components of the sensor 200 in an electronic package orchip. For example, the treatment system 100 and sensor 200 may share thesame processor.

The processor 201 may be coupled to and may receive user input data fromand/or output user input data to the memory 202, the power supply 203,the IR emitter 204, the IR depth sensor 205, the color sensor 206, thetilt monitor 207, the microphone array 208, and/or other peripherals209. The processor 201 may access information from, and store data in,memory 202, such as non-removable memory and/or removable memory. Thenon-removable memory may include random-access memory (RAM), read-onlymemory (ROM), a hard disk, or any other type of memory storage device.The removable memory may include a subscriber identity module (SIM)card, a memory stick, a secure digital (SD) memory card, and the like.The processor 201 may access information from, and store data in, memorythat is not physically located within the sensor 200, such as on thetreatment system 100, on a server (not shown), etc.

The processor 201 may receive power from the power supply 203, and maybe configured to distribute and/or control the power to the othercomponents in the sensor 200. The power supply 203 may be any suitabledevice for powering the sensor 200.

FIG. 3 is a diagram of an example procedure for creating a fitted headmodel. Although FIGS. 3-6 (e.g., the procedure 300) are described withreference to the treatment system 100, the procedure 300 may beperformed by any system, for example, another therapeutic and/ordiagnostic system. Further, although described with reference to a headmodel, the treatment system 100 may be configured to generate a model ofany part of the human subject 120, such as, but not limited to, the arm,neck, chest, leg, and/or the like. In one or more embodiments, one ormore of the processes (e.g., 302, 304, 306, 308, 310, and/or 312) of theprocedure 300 may be omitted.

The treatment system 100 may be started at 302. At 304, the treatmentsystem 100 may determine one or more points that are associated with thehead of the human subject 120. The one or more points that areassociated with the head of the human subject 120 may be referred to asa cloud of points or point cloud. The treatment system 100 may determinethe point cloud using the sensor 110. The treatment system 100 may usethe point cloud to generate a fitted head model, for example, asdescribed herein. A point may be representative of a relative spatiallocation on the human subject's head. For example, a point (e.g., eachpoint) of the cloud of points may comprise an x coordinate, a ycoordinate, and a z coordinate in a coordinate system (e.g., Cartesiancoordinate system, a cylindrical coordinate system, and/or the like).The treatment system 100 may use the sensor 110 to determine therelative location of a point (e.g., each point of the cloud of points)with respect to the sensor 110. The treatment system 100 may determinethe cloud of points using the sensor 110 with or without the use of anadditional tool, for example, as described herein.

The treatment system 100, via the sensor 110, may determine the relativelocation of the cloud of points without the use of an additional tool.The sensor 110 may capture one or more images of the human subject'shead. For example, the sensor 110 may be placed in a scan mode and movedaround the human subject's head. As the sensor 110 is moved, the sensorpose (e.g., the sensor's location and/or orientation) may be tracked andthe sensor 110 may capture one or more views of the human subject'shead. After collecting multiple views of the human subject's head inscan mode, the treatment system 100 may determine the pose of one ormore captured frames and/or how a captured frame relates (e.g., isoriented) to other captured frames. The treatment system 100 may use theone or more images to determine the cloud of points.

The treatment system 100, via the sensor 110, may determine the relativelocation of the cloud of points using an additional tool, for example,an indicator tool. The indicator tool may be another sensor, areflector, a fiducial, and/or other tool that the sensor 110 may use todetermine the relative location of a point. The indicator tool may beused by a technician to indicate the location of the one or more pointson the human subject's head. The treatment system 100 may determine therelative location of a point (e.g., each point of the cloud of points)with respect to the sensor by calculating the distance between thesensor 110 and the indicator tool. For example, the technician may touchthe indicator tool to a particular point on a human subject's head. Whenthe indicator tool is touching the point, the sensor 110 may detect therelative location of the indicator tool. For example, the indicator toolmay send a signal (e.g., an IR transmission, an RF transmission, and/orthe like) to the sensor 110. The signal may be a reflected signal thatis redirected by the indicator tool back to the sensor 110 (e.g., asignal that originated at the sensor 110), sent directly from theindicator tool (e.g., originated at the indicator tool), and/or thelike. The indicator tool may send the signal to the sensor 110 upon aninstruction from the technician, for example, via the user interface ofthe treatment system.

A subset of the points of the cloud of points may comprise facialfeature information. Facial feature information may include the locationof one or more of the human subject's facial features. A facial featuremay be, for example, the human subject's eye(s), nose, ear(s), mouth,chin, hairline, and/or the like. The treatment system 100 may determinethat a subset of the points comprise facial feature information, forexample, based on information provided from the sensor 110 and/or basedon post-processing performed by the treatment system 100. For example,the sensor 110 may determine which points are relating to facialfeatures of the human subject 120, and provide that information to thetreatment system 100 along with the plurality of points. In one or moreembodiments, the treatment system 100 may use the sensor 110 todetermine the location of one or more facial features without the use ofan additional tool. For example, the treatment system 100 may determineone or more facial features by capturing one or more images of the humansubject's head using the sensor 110, and using recognition software toidentify the facial features.

At 306, the treatment system 100 may be configured to generate a fittedhead model, which for example, may be referred to as head surfacemodeling. The treatment system 100 may generate the fitted head modelusing a predetermined head model and the plurality of points. Thetreatment system 100 may generate the fitted head model using a cubicspline method. The treatment system 100 may orient the predeterminedhead model to the plurality of points. The treatment system 100 may, forexample, morph (e.g., stretch) the predetermined head model to theplurality of points to generate the fitted head model. FIGS. 4 and 5 maybe used to describe examples of how the treatment system 100 maygenerate a fitted head model at 306. Upon creation, the fitted headmodel may be saved in memory and associated with the human subject 120,for example, so that it can be recalled and used for subsequenttherapeutic and/or diagnostic procedures.

FIG. 4 is a diagram of an example of a predetermined head model, a pointcloud, and a fitted head model. For example, the treatment system 100may generate the fitted head model 420 using the predetermined headmodel 401 and the plurality of points 410. The predetermined head model401 may be a generic head model that does not include anycharacteristics that are specific to one individual. A predeterminedhead model 410 may be used, for example, to keep the anonymity of thehuman subject 120, to provide information relating to one or morepredefined coordinates, to reduce the total number of artifacts in thefitted head model, to reduce or eliminate the asymmetric nature orabnormal features of the human subject 120 (e.g., loss of ear,asymmetric bump, etc.), and/or the like.

The plurality of points 410 may comprise facial feature information 411a-c. The facial feature information 411 a-c may include the relativelocation of one or more of the human subject's facial features. Forexample, the points 411 a may comprise information relating to therelative location of the human subject's right ear, points 411 b maycomprise information relating to the relative location of the humansubject's right eye, and points 411 c may comprise information relatingto the relative location of the human subject's nose. Although facialfeature information relating to the human subject right ear, right eye,and nose are identified in the example in FIG. 4, it should beunderstood that more or less facial feature information may be providedby a point cloud.

FIG. 5 is a diagram of an example of a predetermined head modelsuperimposed with a plurality of points determined by a sensor. Thepredetermined head model 500 may be an example of the predetermined headmodel 401. The plurality of points may be an example of the point cloud410. The points 510 are a subset of the plurality of points that may bedetermined by a sensor (e.g., the sensor 110, sensor 200, and/or thelike). It should be understood that not all points of the point cloudare labeled 510 for purposes of simplicity and clarity. As shown by theexample of FIG. 5, some (e.g., all) of the points of the point cloud maynot correspond directly with the predetermined head model 500. Thetreatment system 100 may generate the fitted head model using thepredetermined head model 500 and the point cloud 510, for example, bymorphing the predetermined head model 500 to the point cloud 510. Assuch, the fitted head model may have a similar look and feel as thepredetermined head model 500, but to the dimensions of the point cloud510 determined by the sensor.

Although not illustrated in the example in FIG. 4, the predeterminedhead 401 model may comprise predefined coordinates, for example, such asan EEG 10-20 coordinate grid, one or more treatment locations, and/orthe like. The predetermined head model 401 may include locationinformation relating to the one or more anatomical landmarks. Ananatomical landmark may comprise a nasion, an inion, a lateral canthus,an external auditory meatus (e.g., ear attachment point), and/or one ormore preauricular points of the human subject. An anatomical landmarkmay be associated with an x coordinate, a y coordinate, and a zcoordinate of the predetermined head model 401.

The treatment system 100 may generate the fitted head model 420 usingthe predetermined head model 401 and the plurality of points 410. Thefitted head model 420 may have a smooth surface. For example, the fittedhead model 420 may have a smooth surface because it is created using apredetermined head model that also has a smooth surface. Further, in oneor more embodiments, the treatment system 100 may determine that one ormore points of the point cloud 410 are associated with rippling of thehuman subject's skin, loss of a facial feature, and/or an asymmetriclump, and generate the fitted head model 420 without the use of thethese points. For example, the treatment system 100 may recognize anunusual fluctuation between points, an asymmetry between points onopposite sides of the head, and/or a variance between the points andthat of the predetermined head mode 401, and determine that one or morepoints of the point cloud 410 are associated with rippling of the humansubject's skin, loss of a facial feature, and/or an asymmetric lump. Thetreatment system 100 may not use these points when generating the fittedhead model 420.

The fitted head model 420 may not include the human subject's hair. Thetreatment system 100 may identify, exclude, and/or remove the humansubject's hair (e.g., facial hair and/or head hair) from the fitted headmodel 420. The hair may act as interference when generating the fittedhead model 420. The exclusion of the human subject's hair may improvethe accuracy when determining one or more target locations, for example,a MT location, a treatment location, and/or the like. The removal and/orexclusion of the human subject's hair from the fitted head model 420 maybe performed by the treatment system 100 in one or more ways, which forexample, may be performed in any combination.

The treatment system 100 may determine that one or more points of thepoint cloud 410 that are used to create the fitted head model 420 areassociated with the human subject's hair. Thereafter, the treatmentsystem 100 may generate the fitted head model 420 without the use of thepoints associated with the human subject's hair. For example, thetreatment system 100 may use the human subject's facial features (e.g.,those in close proximity to the hair in the front and/or back of thehead) as a guide to determine the location of the hair, which forexample, may be performed since the sensor's scan of the human patientmay include the face of the human subject along with the rest of thehuman subject's head. The treatment system 100 may determine one or morelocation of the surface of the head under the hair using a probe (e.g.,finger, tool, etc.) and use these locations to determine the location ofthe hair (e.g., the points in the point cloud that rest outside of theselocations). The treatment system 100 may estimate the surface of thehead under the hair using one or more facial features and/or anatomicallandmarks. For example, removal of the hair may be performed byestimating intermediate points and using the intermediate points to mapthe head that is under the hair. The treatment system 100 may generateand use a mathematical head model using the known facial features and/oranatomical landmarks. A gel that is visible to the sensor 110 (e.g.,detectable via IR) may be spread on the hair of the patient, such thatthe treatment system 100 may determine which of the plurality of pointsdetected by the sensor 110 correspond to the human subject's hair andexclude those points when generating the fitted head model 420.

The plurality of points that are captured using the sensor 110 and usedto create the fitted head model 420 may be devoid of informationrelating to the human subject's hair, such that the fitted head model420 is devoid of information relating to the human subject's hair whenit is generated by the treatment system 100. For example, the sensor 110may comprise an IR sensor and the hair may not be recognized by thesensor 110. The sensor 110 may detect the warm (e.g., warmer) parts ofthe surface of the head under the hair through the hair and collectpoints that represent the surface of the head under the hair, but notthe hair itself. A solution (e.g., liquid, gel, and/or the like) that isvisible to the sensor 110 (e.g., detectable via IR) may be spread on thehair of the patient, such that the sensor 110 may detect the hair andexclude it from plurality of points that are used by the treatmentsystem 100 to generate the fitted head model 420. The treatment system100 may use an object (e.g., the TMS coil, the doctors hand, and/or thelike) to compress the hair. For example, the object may be moved aroundthe head, and the sensor 110 may recognize the object and determine thelocation of the surface of the head under the hair. The treatment system100 may use a compression cap (e.g., swim cap) that is placed on thehuman subject's head to compress the hair to the surface of the head.

The treatment system 100 may generate the fitted head model 420 usingthe sensor 110 without the use of any additional tools. However, in oneor more embodiments, the treatment system 100 may use one or moreadditional tools to generate the fitted head model 420. The additionaltools may be used in conjunction with the sensor 110. The additionaltools may include, but are not limited to, an indicator tool, areflector, a fiducial, and/or the like, for example, as describedherein.

The fitted head model 420 may include one or more reference points, forexample, such as predefined coordinate systems (e.g., an EEG 10-20coordinate grid) that may be used for a therapeutic and/or diagnosticprocedure, one or more target and/or treatment locations, and/or thelike. FIG. 6 is a diagram of an example fitted head model that includesan EEG 10-20 coordinate grid. The fitted head model 600 may be anexample of the fitted head model 420. The fitted head model 600 maycomprise EEG 10-20 coordinate grid locations 610. The EEG 10-20coordinate grid locations 610 may be used to determine one or moretarget locations and/or treatment locations. A target location (e.g.,the motor threshold (MT) location) may be a reference point used todetermine a treatment location. A treatment location may be used as theposition for the treatment coil 102 for the diagnostic and/ortherapeutic treatment, and/or the like.

The fitted head model 420 may include information relating to one ormore facial features. For example, the facial feature information may beprovided via the cloud of points 410. The facial feature information maybe registered with the fitted head model 420. In one or moreembodiments, the technician may identify and/or confirm a facial featureusing a gesture, for example, by placing a finger on the facial feature.The treatment system 100 may determine the gesture using the sensor 110,for example, to identify that the technician's finger is on the facialfeature. Once identified, the technician may confirm the facial featurevia the user interface before the facial feature is registered with thefitted head model 420 by the treatment system 100.

At 308, the treatment system 100 may determine one or more anatomicallandmarks and associate the anatomical landmarks on the fitted headmodel. This may be referred to as anatomical landmark registration. Thetreatment system 100 may determine one or more anatomical landmarkswithout the use of additional image information, such as MRI images,computer tomography (CT) images, an X-ray image, and/or the like. Ananatomical landmark may comprise a nasion, an inion, a lateral canthus,an external auditory meatus (e.g., ear attachment point), and/or one ormore preauricular points of the human subject 120. An anatomicallandmark may be associated with an x coordinate, a y coordinate, and a zcoordinate of the fitted head model. The treatment system 100 mayregister the anatomical landmarks with the fitted head model.

The treatment system 100 may determine the location of the anatomicallandmarks using the facial feature information provided via the pointcloud. For example, the treatment system 100 may perform triangulationand/or trilateration using the facial feature information (e.g., one ormore points associated with the facial feature information) to determinethe location of one or more anatomical landmarks of the human subject onthe fitted head model. In one or more embodiments, the treatment system100 may determine the location of the anatomical landmarks using thefacial feature information provided via the point cloud if thepredetermined head model does not include information relating to theanatomical landmarks

The fitted head model may comprise the one or more anatomical landmarkswhen it is generated by the treatment system 100. For example, thetreatment system 100 may integrate the anatomical landmarks from thepredetermined head model into the fitted head model when created, forexample, using the facial feature information as indicators of thespecific location of the anatomical landmarks.

The treatment system 100 (e.g., using the sensor 100) may identify theanatomical landmarks and the technician may confirm the identificationof the anatomical landmarks, for example, to associate the anatomicallandmarks with the fitted head model. The technician may confirm theidentification of the anatomical landmarks via the user interface of thetreatment system 100.

The treatment system 100 may determine the anatomical landmarks usingthe sensor 110 with or without the use of an additional tool, such as anindicator tool. For example, the treatment system 100, via the use of anadditional tool, may confirm the location of the anatomical landmarksafter the fitted head model is created. For example, the technician maytouch the additional tool to a particular location on a human subject'shead. When the additional tool is touching the location, the sensor 110may detect the relative location of the additional tool. For example,the additional tool may send a signal (e.g., an IR transmission, an RFtransmission, and/or the like) to the sensor 110. The signal may be areflected signal that is redirected by the indicator tool back to thesensor (e.g., originated at the sensor 110), sent directly from theadditional tool (e.g., originated at the additional tool), and/or thelike. The additional tool may send the signal to the sensor upon aninstruction from the technician, for example, via the user interface ofthe treatment system 100.

Once associated with the fitted head model, the anatomical landmarks maybe used to assist in the therapeutic and/or diagnostic procedure of thehuman subject. For example, the anatomical landmarks may be used toassist the technician in neuronavigation of the human subject's head.Further, the anatomical landmarks may be used to identify and/or storelocations that may be used for therapeutic and/or diagnostic procedure,for example, the MT location and/or treatment location of the humansubject. In one or more embodiments, anatomical landmark registrationmay be performed prior to the procedure (e.g., each procedure) for thehuman subject, for example, to orient the fitted head model with thehuman subject's actual head.

In one or more embodiments, the treatment system 100 may generate thefitted head model using the cloud of points without the use of apredefined head model. For example, the treatment system 100 maydetermine the cloud of points using a scan mode of the sensor, and mayintegrate one or more frames captured by the sensor to generate thefitted head model.

At 310, the treatment system 100 may determine one or more targetlocations on the fitted head model using the anatomical landmarks. Atarget location may be a treatment location or a reference point that isused to determine a treatment location, for example, the MT locationand/or treatment location of the human subject 120. The treatment system100 may determine a target location on the fitted head model based onone or more anatomical landmarks without the use of additional imageinformation, for example, such as, but not limited to an MRI image, a CTimage, and X-ray image, and/or the like.

The anatomical landmarks may be used to assist in neuronavigation of thehuman subject's head. For example, the treatment system 100 may displaythe fitted head model, the anatomical landmarks, and/or a targetlocation on the display device, for example, to assist in a therapeuticor diagnostic procedure. For example, the treatment system 100 mayperform TMS using the fitted head model and/or the target location. Thetreatment system 100 may save the fitted head model, along with theanatomical landmarks and/or target locations, for example, so that itcan be recalled and used during a subsequent therapeutic or diagnosticprocedure.

The treatment system 100 may include software that may performneuronavigation, for example, to assist in the therapeutic and/ordiagnostic procedure of the human subject. For example, the treatmentsystem 100 may comprise software that may perform neuronavigation forTMS treatment. Neuronavigation may refer to the procedure by which thetreatment system 100 allows for a technician to navigate in and/oraround a head, a vertebral column, and/or other body part of a humansubject, for example, before and/or during a procedure. For example,spatial information that may be part of the fitted head model may beused by the software for neuronavigation. The neuronavigation may beperformed in real-time. The neuronavigation may track one or moreobjects, for example, simultaneously. As such, the treatment system 100may be used to perform neuronavigation based on 3D IR object recognitionand motion tracking.

FIG. 7 is a diagram illustrating example procedures for preparing forand/or performing a therapeutic and/or diagnostic procedure. Theprocedures 700, 710 may be performed by a treatment system (e.g., thetreatment system 100) and/or one or more sensors (e.g., sensor 110,sensor 200, and/or the like). Procedure 700 may be performed during thehuman subject's first visit, while procedure 710 may be performed duringa subsequent, repeat visit. In one or more embodiments, one or more ofthe processes (e.g., 701-707 and 711-717) of the procedures 700, 710 maybe omitted. For example, processes 704, 705 may be omitted from theprocedure 700.

At 701, the treatment system may determine an identification (ID) (e.g.,patient ID) for the human subject (e.g., via technician selection). TheID may be an alphanumeric that uniquely identifies the human subject. At702, the human subject may be prepared for the therapeutic and/ordiagnostic procedure. This may include positioning the human subjectpositioning apparatus, positioning a treatment coil with respect to thehuman subject, positioning one or more sensors with respect to the humansubject's head, and/or positioning the human subject in the properorientation. The sensor may be used to assist in the positioning of thehuman subject with respect to the one or more other objects (e.g., atreatment coil, additional tool, and/or other therapeutic and/ordiagnostic tool). For example, the sensor may track the relativelocation of an object with respect to the human subject. The treatmentsystem may indicate that the object is in the proper position bysignaling to the technician, by displaying the relative position of theobject and human subject on the display device, and/or the like.

At 703, the treatment system may generate a fitted head model. Forexample, the treatment system may generate the fitted head model inaccordance with one or more of the embodiments described with referenceto FIG. 3. The treatment system may determine a cloud of points using atleast one sensor, and for example, without the use of an indicator tool.The cloud of points may comprise facial feature information. A facialfeature may include, but is not limited to, a nose, an eye, an ear, achin, hairline, and/or a mouth of the human subject. Facial featureinformation may include information relating to a relative location ofone or more facial features of the human subject. The sensor maydetermine the relative location of one or more points (e.g., each pointof the cloud of points) with respect to the sensor, and feed thisinformation back to the treatment system. After the cloud of points isdetermined using the sensor, the cloud of points may be stored by thetreatment system and/or used for generating the fitted head model.

The treatment system may generate the fitted head model using the cloudof points, for example, using a cubic spline method and/or the like. Forexample, the treatment system may use the cloud of points to morph(e.g., scale) a predefined head model to generate the fitted head model.The treatment system may generate the fitted head model using the cloudof points without the use of a predefined head model. For example, thetreatment system may determine the cloud of points using a scan mode ofthe sensor, and may integrate one or more frames captured by the sensorto generate the fitted head model. As such, the treatment system may mapthe cloud of points to generate the fitted head model, morph apredetermined head model using the cloud of points to generate thefitted head model, integrate a plurality of captured frames to generatethe fitted head model, and/or the like.

In one or more embodiments, the predetermined head model may includeinformation relating to one or more reference points, such as, but notlimited to a standardized set of reference points, such as, an EEG 10-20coordinate grid, for example. The treatment system may generate a fittedhead model that includes an overlaid reference grid (e.g., as shown inFIG. 6). For example, the reference points may be integrated into thefitted head model when generated. The reference grid may be used toassist the technician in locating a target location.

The fitted head model may have a smooth surface. The treatment systemmay generate the fitted head model without the human subject's hair, forexample, as described herein. In one or more embodiments, the treatmentsystem may determine that one or more points of the point cloud areassociated with rippling of the human subject's skin, loss of a facialfeature, an asymmetric lump, and/or the like, and generate the fittedhead model without the use of the points associated with the rippling ofthe human subject's skin, loss of a facial feature, asymmetric lump,and/or the like.

The treatment system may determine the location of one or moreanatomical landmarks on the fitted head model, for example, using thefacial feature information. The treatment system may determine thelocation of the anatomical landmarks without the use of additional imageinformation, such as, an MRI image, a CT image, an X-ray image, and/orthe like. The treatment system may associate the anatomical landmarkswith the fitted head model. An anatomical landmark may comprise anasion, an inion, a lateral canthus, an external auditory meatus (e.g.,ear attachment point), a preauricular point, and/or the like. In one ormore embodiments, the treatment system may integrate the anatomicallandmarks from the predetermined head model into the fitted head modelwhen created, for example, using the facial feature information asindicators of the specific location of the anatomical landmarks. Thetreatment system may determine the location of the anatomical landmarksusing the facial feature information provided via the point cloud, forexample, if the predetermined head model does not include informationrelating to the anatomical landmarks.

At 704, the treatment system may determine a target location, forexample, based on one or more anatomical landmarks and/or one or morereference points. The target location may be a treatment location or areference point that is used to determine the treatment location. In oneor more embodiments, the target location pay be the human subject'smotor threshold (MT) location. Example methods of determining a humansubject's MT location and/or treatment location may be described in U.S.Patent Application Publication No. 2009/0227830 A1, the contents ofwhich are incorporated herein by reference. The target location may bestored in memory, for example, in association with the fitted headmodel. For example, the target location may be indicated by an icon onthe fitted head model and may be used to assist in the therapeuticand/or diagnostic procedure of the human subject.

The human subject's head may be displayed with one or more referencepoints (e.g., a standardized set of reference points, such as, an EEG10-20 coordinate grid), which may be used for determining the locationof a target location. For example, the human subject's head and/or thefitted head model may be displayed on a display device (e.g., thedisplay device 106) and, for example, a grid of reference points may bedisplayed (e.g., as shown in FIG. 6). For example, the reference pointsmay be overlapped on the human subject's head image and/or fitted headmodel. The grid of reference points may be used to assist in thedetermination of the human subject's MT location and/or treatmentlocation, for example, with or without the use of the indicator tool.The treatment system may determine and store the treatment location, theMT location, and/or other targets on the fitted head model, for example,to assist in a therapeutic and/or diagnostic procedure. For example, inTMS, the treatment system may use the human subject's MT location and/orthe human subject's treatment location when performing treatment. Thehuman subject's MT location and/or treatment location may be displayedwith the fitted head model on the display device when calibrating and/orperforming the therapeutic and/or diagnostic procedure.

After determining a target location of the human subject, the treatmentsystem may determine a target location level for the human subject at705. The target location level may include an amount (e.g., intensity)and/or duration at which an application of a procedure should beperformed at the target location for the human subject, for example, toensure that the target location is correct. For example, if the targetlocation is the MT of the human subject, the MT level may include thestrength of the pulse(s) that are applied to the human subject's MTlocation to induce a thumb twitch. The thumb twitch may indicate thatthe target location is on the human subject's motor strip. The humansubject's target location level may be stored. For example, the humansubject's MT level may be stored in association with the fitted headmodel, for example, by means of an MT level icon.

The human subject's treatment location may be determined at 706, forexample, using the human subject's MT location as a guide. For example,the human subject's treatment location may be determined by moving thetreatment tool (e.g., coil) from the MT location along a line in theanterior direction a prescribed distance (e.g., 5 cm). The resultantlocation may be the human subject's treatment location. The humansubject's treatment location may be stored, for example, in associationwith the fitted head model. For example, the human subject's treatmentlocation may be indicated by an icon that is different than the iconindicating the human subject's MT location. As such, the treatmentsystem may determine the desirable placement location of a therapeuticand/or diagnostic device (e.g., a treatment coil, electrode, a sensor,and/or the like) for the therapeutic/diagnostic procedure of the humansubject.

The treatment system may determine a treatment level for the humansubject at 706. The treatment level may include an amount (e.g.,intensity) and/or duration at which an application of the therapeuticand/or diagnostic procedure should be performed at the treatmentlocation for the human subject.

After the human subject's treatment location is determined and stored,the fitted head model may be used to assist in the therapeutic and/ordiagnostic procedure of the human subject. The fitted head model mayinclude visual aids, for example, anatomical landmarks, reference points(e.g., a standardized set of reference points), marking of the humansubject's motor threshold (MT) location, marking of the human subject'streatment location, and/or the like. The visual aids may assist atechnician to setup and/or perform the therapeutic and/or diagnosticprocedure of the human subject. Therapeutic and/or diagnostic proceduremay be performed at 707. This may include further refinements of thetreatment location during the therapeutic and/or diagnostic procedure.In one or more embodiments, the treatment may comprise TMS.

The treatment system may, for example, track of one or more objects, forexample, before and/or during a treatment procedure. For example, thetreatment system 100 may use one or more sensors to perform objecttracking. The sensor may track the relative location of one or moreobjects, for example, with respect to other objects, and provide suchinformation to the treatment system 100. The object may include anadditional tool, a treatment and/or procedure device (e.g., thetreatment coil 102), a human subject's head, one or more sensors, and/orthe like. For example, the treatment system 100 may use object trackingto assist in navigating the treatment device (e.g., the treatment coil102) to the treatment location of the human subject. Further, thetreatment system 100 may use object tracking during the treatmentprocedure, for example, as described herein. Object tracking may beperformed with or without the use of an additional tool (e.g., afiducial).

The treatment system may track objects by attaching an additional tool(e.g., a reflector, a fiducial, and/or the like) on the treatment coil.The treatment system may track objects without the use of an additionaltool. For example, the sensor may capture one or more images (e.g., inscan mode) to track the location of one or more objects, for example,with the use of recognition software. The treatment system may trackobjects to assist in navigating the treatment coil 102 to the treatmentlocation of the human subject. Further, the treatment system may useobject tracking during the treatment procedure.

During a therapeutic and/or diagnostic procedure, for example, thetreatment and/or procedure device may be in close proximity to the humansubject's head. The treatment and/or procedure device may be moved fromone location to the other, for example, when performing the search forthe human subject's MT location and/or when performing the procedureitself. The location of the treatment and/or procedure device may betracked by the sensor to ensure it does not adversely affect thereadings of the sensor. Further, the indicator tool may be attached tothe human subject's head to more accurately capture the size and shapeof the head, for example, to compensate for the movement of the humansubject's head while capturing the cloud of points and/or the anatomicallandmark registration.

Procedure 710 may be performed during a subsequent, repeat visit of ahuman subject. As such, the treatment system may have a fitted headmodel stored in memory. Procedure 710 may begin with the technicianselecting the ID for the human subject at 711. The ID may have alreadybeen stored and associated with the human subject during a previousvisit. As such, upon selecting the ID, the fitted head model, thetreatment location, and/or the like may be uploaded and displayed by thetreatment system. At 712, the human subject may be prepared for thetherapeutic and/or diagnostic procedure (e.g., which may besubstantially similar to 702).

At 713, the anatomical landmarks may be determined. Since the fittedhead model may have been created and stored during a previous visit, thetechnician may register (e.g., only register) the anatomical landmarksof the human subject. For example, the technician may confirm thelocation of the anatomical landmarks on the fitted head model, forexample, with or without the use of an indicator tool. The location ofthe anatomical landmarks may be confirmed prior to the procedure (e.g.,each procedure) for the human subject, for example, to orient the fittedhead model with the human subject's actual head. Procedure 710 may notinclude the determination of the MT location and/or treatment locationof the human subject, for example, since this information may havealready been created and stored during a previous visit. At 716, thetreatment location and parameters may be recalled from memory and/ordisplayed for the technician (e.g., which may be substantially similarto 706). At 717, the therapeutic and/or diagnostic procedure may beadministered to the human subject (e.g., which may be substantiallysimilar to 707).

One or more of the following, in any combination, may be performed by atreatment system (e.g., the treatment system 100).

The sensor may measure and/or report (e.g., continuously measure and/orreport) the relative position of one or more objects (e.g., tools, thehuman subject, etc.) for display (e.g., real-time display) to thetechnician. For example, the sensor may measure the relative location ofa treatment tool (e.g., a coil) with respect to the human subject'shead. The sensor may determine the location of the treatment coil thatis in contact with the human subject's head (e.g., which portion(s) ofthe treatment tool are in contact with the head). The treatment systemmay use treatment tool's location information to determine if procedureis being performed properly. For example, for TMS, if the treatment coilfalls outside of a predefined range with respect to the human subject'shead (e.g., is too far or too close to the human subject's head), thenthe treatment system may alter or stop the therapeutic and/or diagnosticprocedure.

The treatment system may use the sensor to calibrate a therapeuticand/or diagnostic procedure. For example, the treatment system may usehuman subject recognition software to determine the human subject, thepatient ID, type of tool (e.g., coil type), and/or the parameters of thetherapeutic and/or diagnostic procedure for the human subject based onthe feedback from the sensor.

The treatment system may use voice commands to activate and/or managesetup of a therapeutic and/or diagnostic procedure (e.g., identificationof anatomical landmarks) and/or the procedure itself. For example, thesensor may be used to relay voice commands to the treatment system.

The treatment system may use the sensor to recognize a tool, a humansubject, a logo (e.g., a logo on a tool), and/or the like. The treatmentsystem may authenticate a tool and/or a human subject based on itsrecognition via the sensor. For example, if the treatment systemrecognizes a tool, then the treatment system may allow for treatment ofthe human subject to occur. However, if the treatment system does notrecognize the tool (e.g., if the tool is a sham tool, such as a shamcoil, for example), then the treatment system may prevent theapplication of procedure to the human subject and/or log such activity.The treatment system may recognize and/or authenticate a tool based onthe size of the tool, the shape of the tool, a logo on the tool,invisible IR ink on the tool, sound of the tool, a reflector on thetool, and/or the like. Recognition of a tool may be used for securityand/or safety precautions. The recognition of a tool may be used forcalibration of the therapeutic and/or diagnostic procedure. For example,the treatment system may calibrate the procedure differently based onthe coil type detected via the sensor. The treatment system may verifythat setup is accurate by recognizing one or more tools.

The treatment system may use the sensor to determine whether the humansubject is experiencing a seizure. For example, the treatment systemand/or the sensor may be calibrated with one or more parametersassociated with a signature of a seizure (e.g., shaking of the humansubject in excess of a predetermined amount, etc.). Upon detecting aseizure, the treatment system may adjust or stop the procedure for thehuman subject.

The sensor may be incorporated into augmented reality (AR) goggles. Forexample, the technician may wear the AR goggles. The technician may walkaround the human subject while wearing the AR goggles to determine thecloud of points that the treatment system may use to generate the fittedhead model. The display from the display device of the treatment systemmay be reproduced in AR googles, for example, to assist the technicianin the preparation for the procedure and/or during the procedure.

The treatment system may use the sensor to detect the temperature of atool that is used during a therapeutic and/or diagnostic procedure. Forexample, the treatment system, via the sensor, may detect thetemperature of a coil used for TMS (e.g., using IR). If the treatmentsystem determines that the temperature of the coil falls outside of apredetermined range (e.g., gets too hot or too cold), then the treatmentsystem may adjust or stop the therapeutic and/or diagnostic procedure.This may be performed to ensure the safety of the human subject.

The treatment system may use the sensor to perform eye tracking. Forexample, the sensor may track the human subject's eyes for diagnosticpurposes, for example, to determine whether the procedure is working(e.g., which the human subject is depressed and/or happy), whether thehuman subject is awake/asleep, and/or the like.

The treatment system may use the sensor to detect invisible IR ink, forexample, to prevent reuse of a disposable tool. For example, the streatment system, via the sensor, may read a unique alphanumeric on adisposable tool and cross-reference the alphanumeric with a listing ofpreviously used alphanumerics. If the treatment system determines thatthe alphanumeric matches a previously used alphanumeric, then thetreatment system may prevent the administration of the therapeuticand/or diagnostic procedure. This may be performed for safety, to trackthe number of administered procedures for a human subject and/orfacility, to prevent the use of a counterfeit tool, and/or the like.

The treatment system may use the sensor to read a barcode. For example,prescriptions for a human subject may be sent to the procedure facilityelectronically using encrypted barcodes. The sensor may read thebarcode, and upon authentication, enable the initiation of thetherapeutic and/or diagnostic procedure to the human subject.

The treatment system may use the sensor to remotely monitor a procedure,for example, to ensure accurate calibration and/or safety. For example,the sensor may send a video (e.g., real-time streaming video) to atechnician who may be at a remote location via the treatment system. Thetechnician may watch the procedure (e.g., in real-time) to ensure thatthe procedure is being accurately and safely performed.

The treatment system, via the sensor, may use gesture controls to adjustand/or administer the therapeutic and/or diagnostic procedure to thehuman subject. For example, the treatment system may use the NaturalUser Interface (NUI) for gesture control. The gestures may be used toconfirm the location of the human subject's MT. For example, thetreatment system, using feedback from the sensor, may detect the twitchof the human subject's thumb upon the application a pulsing magneticfield to the human subject's MT location. The human subject's thumb maybe fitted with an additional sensor, for example, to assist thedetection of the twitch by the treatment system.

Although described with reference to the head of a human subject, one ormore of the embodiments described herein may be applied to anatomiesother than the head. For example, the treatment system may be used tocreate a fitted model of an arm, leg, hand, foot, chest, and/or otheranatomy of a human subject. Further, the treatment system may be used tocreate a fitted model of an anatomy of a subject other than humans, suchas birds, amphibians, reptiles, fish, insects, and/or other mammals.

Although features and elements are described above in particularcombinations, one of ordinary skill in the art will appreciate that eachfeature or element can be used alone or in any combination with theother features and elements. In addition, the methods described hereinmay be implemented in a computer program, software, or firmwareincorporated in a computer-readable medium for execution by a computeror processor. Examples of computer-readable media include electronicsignals (transmitted over wired or wireless connections) andcomputer-readable storage media. Examples of computer-readable storagemedia include, but are not limited to, a read only memory (ROM), arandom access memory (RAM), a register, cache memory, semiconductormemory devices, magnetic media such as internal hard disks and removabledisks, magneto-optical media, and optical media such as CD-ROM disks,and digital versatile disks (DVDs).

The invention claimed is:
 1. A system for creating a digitalthree-dimensional reconstruction of a human subject's head, the systemcomprising: a treatment coil; a sensor; and a processor configured to:determine a plurality of points associated with the human subject's headusing the sensor and without requiring the use of magnetic resonanceimaging (MRI) image information, x-ray image information, or computertomography (CT) image information, wherein the plurality of points aredevoid of information relating to the human subject's hair, and whereina subset of the plurality of points comprise facial feature information;generate a fitted head model using a predetermined head model and theplurality of points such that the fitted head model is devoid ofinformation relating to the human subject's hair; determine a locationof one or more anatomical landmarks on the fitted head model using thefacial feature information, the anatomical landmarks comprising one ormore of a nasion, an inion, a lateral canthus, an external auditorymeatus, or one or more preauricular points of the human subject;determine a position of the treatment coil based on the one or moreanatomical landmarks and without requiring the use of magnetic resonanceimaging (MRI) image information, x-ray image information, or computertomography (CT) image information; and perform transcranial magneticstimulation (TMS) at a treatment location using the treatment coil. 2.The system of claim 1, wherein the treatment location corresponds to ananatomical region within a human brain and is associated with aneuropsychiatric disorder.
 3. The system of claim 1, wherein the sensorcomprises an image sensor.
 4. The system of claim 1, wherein theprocessor is configured to determine the plurality of points using thesensor and without the use of an indicator tool.
 5. The system of claim1, wherein one or more of the predetermined head model or the fittedhead model comprises an electroencephalogram 10-20 coordinate grid. 6.The system of claim 1, wherein the fitted head model has a smoothsurface.
 7. The system of claim 1, wherein the processor is furtherconfigured to: determine that one or more points of the plurality ofpoints are associated with rippling of the human subject's skin, loss ofa facial feature, or asymmetric lump; and generate the fitted head modelwithout the use of the one or more points associated with the ripplingof the human subject's skin, loss of a facial feature, or asymmetriclump.
 8. The system of claim 1, further comprising a display device,wherein the processor is further configured to display the fitted headmodel and the treatment location or a reference point that is used todetermine the treatment location on the display device.
 9. The system ofclaim 1, wherein the processor is further configured to: determine asecond treatment location or a reference point that is used to determinethe second treatment location on the fitted head model based on the oneor more anatomical landmarks and without the use of additional imageinformation; and perform TMS at the second treatment location using thefitted head model.
 10. The system of claim 1, wherein the processor isfurther configured to: monitor a position of a TMS coil using the sensorwhile performing TMS; determine that the position of the TMS coil fallsoutside of a predefined range with respect to the human subject's head;and alter or stop performing TMS.
 11. The system of claim 1, wherein theprocessor is further configured to: monitor a temperature of a TMS coilusing the sensor while performing TMS; determine that the temperature ofthe TMS coil falls outside of a temperature range; and alter or stopperforming TMS.
 12. The system of claim 1, further comprising: augmentedreality (AR) goggles that comprise the sensor.
 13. A method for creatinga digital three-dimensional reconstruction of a human subject's head,the method comprising: determining a plurality of points associated withthe human subject's head using a sensor and without requiring the use ofmagnetic resonance imaging (MRI) image information, x-ray imageinformation, or computer tomography (CT) image information, wherein asubset of the plurality of points comprise facial feature information;determining that one or more points of the plurality of points areassociated with the human subject's hair; generating a fitted head modelusing a predetermined head model and a subset of the plurality of pointsthat are not associated with the human subject's hair; determining alocation of one or more anatomical landmarks on the fitted head modelusing the facial feature information, the anatomical landmarkscomprising one or more of a nasion, an inion, a lateral canthus, anexternal auditory meatus, or one or more preauricular points of thehuman subject; determining a treatment location or a reference pointthat is used to determine the treatment location on the fitted headmodel based on the one or more anatomical landmarks and withoutrequiring the use of magnetic resonance imaging (MRI) image information,x-ray image information, or computer tomography (CT) image information;and performing transcranial magnetic stimulation (TMS) at the treatmentlocation using the fitted head model.
 14. The method of claim 13,wherein the treatment location corresponds to an anatomical regionwithin a human brain and is associated with a neuropsychiatric disorder.15. The method of claim 13, wherein the sensor comprises an imagesensor.
 16. The method of claim 13, wherein one or more of thepredetermined head model or the fitted head model comprises anelectroencephalogram 10-20 coordinate grid.
 17. The method of claim 13,further comprising displaying the fitted head model and the treatmentlocation or the reference point that is used to determine the treatmentlocation on a display device to assist in performing TMS.
 18. The methodof claim 13, further comprising: monitoring, while performing TMS, aposition of a TMS coil using the sensor; determining that the TMS coilfalls outside of a predefined range with respect to the human subject'shead; and altering or stopping the performance of TMS.
 19. The method ofclaim 13, further comprising: monitoring, while performing TMS, atemperature of a TMS coil using the sensor; determining that thetemperature of the TMS coil falls outside of a predefined range; andaltering or stopping the performance of TMS.
 20. A method for creating adigital three-dimensional reconstruction of a human subject's head, themethod comprising: determining a plurality of points associated with thehuman subject's head using a sensor by moving a transcranial magneticstimulation (TMS) coil around the human subject's head such that theplurality of points are devoid of information relating to the humansubject's hair, wherein a subset of the plurality of points comprisefacial feature information, and wherein the sensor is configured todetermine the location of the TMS coil; generating a fitted head modelusing a predetermined head model and the plurality of points, such thatthe fitted head model is devoid of information relating to the humansubject's hair; determining a location of one or more anatomicallandmarks on the fitted head model using the facial feature information,the anatomical landmarks comprising one or more of a nasion, an inion, alateral canthus, an external auditory meatus, or one or morepreauricular points of the human subject; determining a treatmentlocation or a reference point that is used to determine the treatmentlocation on the fitted head model based on the one or more anatomicallandmarks and without requiring the use of magnetic resonance imaging(MRI) image information, x-ray image information, or computer tomography(CT) image information; and performing TMS at the treatment locationusing the fitted head model.